BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT

    MDR report key: 2191204 · Received July 29, 2011

    Report

    Report Number
    2953200-2011-01355
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK). RESULTS AND CONCLUSIONS: (AORTIC NECK ANGULATION OF 50 DEGREES).

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN UNK SIZE ABDOMINAL AORTIC ANEURYSM, APPROX TEN AND ONE HALF YEARS AGO. CURRENT VESSEL MORPHOLOGY WAS REPORTED AS THE ANEURYSM IS 11CM; MILD TORTUOSITY AND CALCIFICATION IN THE VESSELS; A SHORTENED NECK; AN AORTIC NECK ANGULATION OF 50 DEGREES; AN AORTIC NECK DIAMETER AT THE RENAL ARTERIES OF APPROX 23 MM. IT WAS REPORTED THAT IN THE PAST, THE PT MUST HAVE HAD A DISTAL TYPE I ENDOLEAK IN THE RIGHT ILIAC THAT HAD EXPANDED WITH THE WHOLE ANEURYSM WHICH NECESSITATED AT LEAST ONE INTERVENTION BECAUSE, THE LIMB HAS BEEN RELINED WITH ANOTHER MFR'S EXTENSION CUFF. IT IS ASSUMED THAT THERE WAS PRIOR SAC EXPANSION, WITH NO ENDOLEAK, SO THEY RELINED THE LIMB DUE TO A TYPE V ENDOLEAK AND THEN WHEN THE ILIAC GOT BIGGER, THE OTHER MFR'S CUFF WAS PLACED. THE PROXIMAL SEAL IS MINIMAL, AT 6 MM BELOW THE RENALS. THE PHYSICIAN COIL EMBOLIZED THE RIGHT HYPOGASTRIC ARTERY AND PLACED AN ENDURANT LIMB FROM THE ANEURX TO EXTERNAL ILIAC ARTERY. THE PHYSICIAN DECIDED TO CORRECT THE IMMEDIATE PROBLEM ONLY, RATHER THAN CONVERTING TO A TALENT CONVERTER TO EXCLUDE THE ANEURX, IN ORDER TO STOP THE ANEURYSM FROM GROWING BECAUSE OF THE POROSITY OF THE OLD STENT GRAFT. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR NA M00J750068

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention